510(k) K863447
K863447 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM II". The FDA issued a decision of Substantially Equivalent on September 29, 1986. The device falls under product code GET (Motor, Surgical Instrument, Pneumatic Powered), a Class I device regulated under 21 CFR 878.4820. Stryker Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 1986
- Date Received
- September 8, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Surgical Instrument, Pneumatic Powered
- Device Class
- Class I
- Regulation Number
- 878.4820
- Review Panel
- SU
- Submission Type